The future of osteoporosis treatment

October 7, 2004

Browing Medscape this morning (a daily routine) I found these two intriguing stories – Parathyroid Hormone Nasal Spray Shows Promise Against Osteoporosis

Early clinical results indicate that an investigational once-daily nasal spray of parathyroid hormone stimulates the growth of healthy bone quickly with results comparable to injectable forms of the hormone, according to lead investigator Toshio Matsumoto, MD, professor and chairman of the department of medicine and bioregulatory sciences at the University of Tokushima Graduate School of Medicine in Japan.

“We believe that because nasal hPTH(1-34) increases bone formation while reducing bone resorption, it makes it a promising candidate for the treatment of osteoporosis,” said Dr. Matsumoto.

In an oral presentation here at the 26th annual meeting of the American Society for Bone and Mineral Research (ASBMR), Dr. Matsumoto said that the parathyroid compound, being developed by Chugai Pharmaceutical Co., Ltd., of Tokyo, Japan, resulted in significant bone mineral density (BMD) increase compared with baseline at three months using the 1,000 mcg dose of the recombinant hormone.

In the study, 92 osteoporotic women aged 52 to 84 years were enrolled. The women were randomly assigned to receive either 250 mcg (PTH250, n = 31), 500 mcg (PTH500, n = 30), or 1,000 mcg (PTH1000, n = 31) of daily nasal hPTH(1-34) spray for three months. In addition, all participants received supplemental calcium (300 mg) and 200 IU of vitamin D daily.

After three months, in the 31 women with osteoporosis who received the highest dose, lumbar spine BMD had increased by 2.4% compared with baseline measurements (P < .05). There were insignificant BMD increases among the women randomized to the 250-mcg or 500-mcg doses.

While these are preliminary data – they do suggest that PTH may become a very acceptable alternative for osteoporosis treatment. Two cautions: 1. Initial costs will likely be significant; 2. We should carefully examine potential side effects in long term trials. Thus, we have an intriguing future possibility, but emphasize the word future.

Once Monthly Ibandronate as Effective as Daily Ibandronate for Osteoporosis

One-year results from a study comparing a once-monthly investigational regimen of oral ibandronate to daily ibandronate for treatment of postmenopausal osteoporosis suggests that the monthly treatment is at least as effective as the daily regimen. In addition, the high-dose monthly regimen (150 mg/month) was associated with the greatest increase in bone mineral density (BMD).

It is widely acknowledged that adherence to oral daily and weekly bisphosphonates is suboptimal, which has prompted a number of pharmaceutical companies to pursue new, more patient-friendly regimens as a means to increase compliance. The once-monthly ibandronate formulation (Boniva) is being developed by Roche/GlaxoSmithKline to overcome the adherence-gap.

But some critics think once-monthly is too infrequent:

But while monthly treatment was efficacious, Dr. Miller told Medscape that he is not convinced that a monthly regimen will improve adherence, which is the “holy grail” of osteoporosis treatment.

“Improved compliance may not occur in the real world of clinical practice. From my own perspective, I would rather take a drug on a daily basis,” Dr. Miller said in an interview. He noted that he takes a statin “every night before I go to bed so it becomes a habit.” Asked about the seeming contradiction between his role as lead investigator for a study of an investigational monthly regimen, Dr. Miller said, “My job isn’t to sell drugs. My job is the science. This is the science and it shows that the results are clear. The monthly regimen is effective.”

Jane Cauley, DrPH, an associate professor at the University of Pittsburgh in Pennsylvania, told Medscape that results of MOBILE are encouraging because “what we need is adherence.” Dr. Cauley, who was not involved in the study, noted that daily bisphosphonate treatment is not as simple as taking a pill a bedtime. “Daily treatment takes time away from a woman’s morning schedule and that makes adherence difficult.”

Weekly formulations improve adherence because “a woman can get on a schedule where she takes the drug on the same day every week,” Dr. Cauley said. With a monthly formulation, “women might forget to take the drug.” But she noted that it might be possible to safeguard against forgetfulness by linking the medication to a regular monthly routine such as paying the mortgage or paying a utility bill.

As Rangel says, Opinions are like sphincters, everyone has one. Prospective studies of real patients will answer the question of daily versus weekly versus monthly. I certainly like the idea of once monthly medication.

My parents both take Fosamx weekly (when I first learned of the weekly regimen I had my mother ask her physician about that option). The both like the once weekly regimen. I suspect that given the choice, some patients would choose once weekly, and some would choose once monthly. Both would likely trump daily.

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